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OncoMatch/Clinical Trials/NCT06492616

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

Is NCT06492616 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast cancer.

Phase 3RecruitingStemline Therapeutics, Inc.NCT06492616Data as of May 2026

Treatment: Elacestrant · Anastrozole · Letrozole · Exemestane · TamoxifenThe primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 overexpression (ER-positive, ≥ 10% by IHC) (≥ 10% by IHC)

ER-positive (≥ 10% by immunohistochemistry [IHC])

Required: HER2 (ERBB2) negative (IHC = 0, 1+, 2 and ISH-negative) (IHC = 0, 1+, 2 and ISH-negative)

HER2-negative [IHC = 0, 1+, 2 and in situ hybridization [ISH]-negative)]

Prior therapy

Must have received: endocrine therapy (aromatase inhibitor, tamoxifen) — adjuvant

Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Southern Cancer Center, PC · Daphne, Alabama
  • Ironwood Cancer and Research Centers · Chandler, Arizona
  • Banner MD Anderson Cancer Center · Gilbert, Arizona
  • Mayo Clinic · Scottsdale, Arizona
  • Arizona Clinical Research Center, Inc. · Tucson, Arizona

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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